For Patients

Juxtapid (lomitapide) is indicated as an adjunct to a low-fat diet and other lipid-lowering treatments to help manage cholesterol. Juxtapid belongs to a class of drugs called microsomal triglyceride transfer protein inhibitors. The most common adverse reactions are diarrhea, nausea, vomiting, dyspepsia, and abdominal pain.

Juxtapid is taken orally . Juxtapid should be taken once daily, whole, with water and without food, at least 2 hours after evening meal. While on Juxtapid therapy, patients must avoid grapefruit juice. CYP3A4 inhibitors such as Serzone, Sporanox, Nizoral, Vfend, Reyataz, Biaxan and Ketek are contraindicated with Juxtapid. Juxtapid also reacts with warfarin (Coumadin), simvastatin (Zocor), and lovastatin (Altocor, Altoprev, Mevacor). Before treatment, women of reproductive potential must test negative for pregnancy. Juxtapid should not be used in pregnant women or nursing mothers.

Our Juxtapid (lomitapide) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Clinical Trials Experience

Because clinical trials are conducted under widely
varying conditions, adverse reaction rates observed in the clinical trials of a
drug cannot be directly compared to rates in the clinical trials of another
drug and may not reflect the rates observed in practice.

One single-arm, open-label, 78-week trial has been
conducted in 29 patients with HoFH, 23 of whom completed at least one year of
treatment. The initial dosage of JUXTAPID was 5 mg daily, with titration up to
60 mg daily during an 18-week period based on safety and tolerability. In this
trial, the mean age was 30.7 years (range, 18 to 55 years), 16 (55%) patients
were men, 25 (86%) patients were Caucasian, 2 (7%) were Asian, 1 (3%) was
African American, and 1 (3%) was multi-racial [see Clinical Studies].

Five (17%) of the 29 patients with HoFH that participated
in the clinical trial discontinued treatment due to an adverse reaction. The
adverse reactions that contributed to treatment discontinuations included
diarrhea (2 patients; 7%) and abdominal pain, nausea, gastroenteritis, weight
loss, headache, and difficulty controlling INR on warfarin (1 patient each;
3%).

Transaminase Elevations

During the HoFH clinical trial,
10 (34%) of 29 patients had at least one elevation in ALT and/or AST ≥ 3x
ULN (see Table 4). No clinically meaningful elevations in total bilirubin or
alkaline phosphatase were observed. Transaminases typically fell within one to
four weeks of reducing the dose or withholding JUXTAPID.

Upper limits of normal (ULN)
ranged from 33-41 international units/L for ALT and 36-43 international units/L
for AST.

Among the 19 patients who
enrolled in an extension study following the HoFH clinical trial, one
discontinued because of increased transaminases that persisted despite several
dose reductions, and one temporarily discontinued because of markedly elevated
transaminases (ALT 24x ULN, AST 13x ULN) that had several possible causes, including
a drug-drug interaction between JUXTAPID and the strong CYP3A4 inhibitor
clarithromycin [see DRUG INTERACTIONS].

Hepatic Steatosis

Hepatic fat was prospectively
measured using magnetic resonance spectroscopy (MRS) in all eligible patients
during the HoFH clinical trial. After 26 weeks, the median absolute increase in
hepatic fat from baseline was 6%, and the mean absolute increase was 8%
(range, 0% to 30%). After 78 weeks, the median absolute increase in hepatic fat
from baseline was 6%, and the mean absolute increase was 7% (range, 0% to 18%).
Among the 23 patients with evaluable data, on at least one occasion during the
trial, 18 (78%) exhibited an increase in hepatic fat > 5% and 3 (13%)
exhibited an increase > 20%. Data from individuals who had repeat
measurements after stopping JUXTAPID show that hepatic fat accumulation is
reversible, but whether histological sequelae remain is unknown.